BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM 20DP CKV 3SS DEHP FREE

    MDR report key: 11898939 · Received May 27, 2021

    Report

    Report Number
    9616066-2021-51174
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    April 14, 2021
    Report Date
    June 9, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY ONE UNUSED PRIMARY SET, MODEL 2426-0007 LOT 21029017, WAS RECEIVED BY THE CUSTOMER FOR INVESTIGATION. UPON VISUAL INSPECTION, IT COULD BE OBSERVED THAT THE SILICON TUBING PUMPING SEGMENT WAS DISCONNECTED FROM THE LOWER FITMENT. NO OTHER DEFECTS WERE OBSERVED. THE CUSTOMER'S COMPLAINT THAT THE IV TUBING WAS APART IMMEDIATELY UPON REMOVING FROM PACKAGING WAS VERIFIED. THE EXPECTED RETAINER RING FOR THIS ENGAGEMENT WAS NOT RECEIVED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2426-0007 LOT NUMBER 21029017 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF 28,803 UNITS IN 1 LOT NUMBER WAS BUILT ON 15FEB2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. VISUAL INSPECTION UNDER MAGNIFICATION WAS PERFORMED ON THE SILICON PUMPING SEGMENT. NO INDENTATION OF THE RETAINER RING COULD BE OBSERVED AT THE END OF THE TUBING. THE POTENTIAL ROOT CAUSE FOR THE SILICON SEPARATION DEFECT IS INADEQUATE HANDLING OF THE SET THAT MAY CAUSE OF MOVEMENT OF RINGS PROVOKING A SKEW IN SILICON AND LOWER FITMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GEM 20DP CKV 3SS DEHP FREE EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2426-0007 BATCH NO: 21029017 IV TUBING WAS APART IMMEDIATELY UPON REMOVING FROM PACKAGING.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GEM 20DP CKV 3SS DEHP FREE EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2426-0007 . BATCH NO: 21029017. IV TUBING WAS APART IMMEDIATELY UPON REMOVING FROM PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794852 GEM 20DP CKV 3SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 21029017

    Patients

    Seq Age Sex Outcome Treatment
    1